FMEA – failure mode and effects analysis

Template

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.
In this pipe, a systematic method consisting of 10 steps is used to develop and manage the FMEA document.

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Template structure

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  • 1. Process or product name

  • 2. FMEA number

  • 3. Process owner

  • 4. Prepared by

  • 5. FMEA date

  • 6. Review

FMEAs to be performed

  • 1. What is the deadline for completing the FMEA?

1. Key process step

  • 1. List each process component in the FMEA table

2. Potential failure modes

  • 1. List the potential failure mode for each process step.

3. Potential failure effects

  • 1. List potential effects of each failure.

4. Severity

  • 1. Based on failure consequences, rate how severe each effect is considering 1 as not severe at all and 10 as extremely severe.

5. Occurrence

  • 1. Identify the causes of the failure mode/effect.

  • 2. Rate the causes considering 1 as highly unlikely to ever occur and 10 as expected to happen all the time.

6. Detection

  • 1. Identify the controls in place to detect the issue.

  • 2. Rate detection control effectiveness considering 1 as excellent control and 10 as no control or extremely weak control.

7. RPN

  • 1. Calculate the RPN of all the listed effects.

8. Action plan

  • 1. Action plan

  • 2. Checklist

    • Decide which failures will be worked on based on the Risk Priority Numbers.
    • Define actions for reducing the occurrence of the cause or improving detection.
    • Define who is responsible for the recommended action.

9. Actions taken

  • 1. Implement the improvements identified by your FMEA team.

10. New RPN

  • 1. Reevaluate each of the potential failures once improvements have been made and determine the impact of the improvements.

Done

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